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Stark Law is a set of United States federal laws that prohibit physician self-referral, specifically a referral by a physician of a Medicare or Medicaid patient to an entity for the provision of designated health services ("DHS") if the physician (or an immediate family member) has a financial relationship with that entity.
In patent law, the research exemption or safe harbor exemption is an exemption to the rights conferred by patents, which is especially relevant to drugs.According to this exemption, despite the patent rights, performing research and tests for preparing regulatory approval, for instance by the FDA in the United States, does not constitute infringement for a limited term before the end of patent ...
The ability to self-refer is an incentive for physicians to order more tests than they otherwise might. In the United States, the Stark Law (specifically sections I and II) was designed to control self-referrals. [2] However, the exceptions designed to allow necessary testing in physicians' offices have been exploited to circumvent the law.
Safe harbor provisions appear in a number of laws and in many contracts. An example of safe harbor in a real estate transaction is the performance of a Phase I Environmental Site Assessment by a property purchaser: creating a "safe harbor" protecting the new owner if, in the future, contamination caused by a prior owner is found. Another common ...
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The Anti-Kickback Statute [1] (AKS) is an American federal law prohibiting financial payments or incentives for referring patients or generating federal healthcare business. . The law, codified at 42 U.S. Code § 1320a–7b(b), [2] imposes criminal and, particularly in association with the federal False Claims Act, civil liability on those who knowingly and willfully offer, solicit, receive ...
Five years ago, the city of Beaufort ran afoul of South Carolina state law when it authorized a 40-year lease with Safe Harbor Marinas to run its downtown marina, the city manager acknowledged on ...
[13] [14] In August 2021, Aristotle, Inc. withdrew from the safe harbor program after FTC staff expressed serious concerns about its enforcement of its safe harbor provisions and communicated their intent to recommend the revocation of Aristotle's approval to run a safe harbor program. The FTC also announced its intention to more closely ...